Associate Director, GMP Operational Quality
Vertex Pharmaceuticals
September 02, 2026
Remote friendly (Boston, MA)
United States
Operations
Associate Director, GMP Operational Quality (On-Site)
Location/Shift: On-Site at Vertex’s Leiden Center Building (LC1), 316-318 Northern Ave, Boston, MA 02210. 1st shift B1: Wed–Sat 7:00am–5:30pm.
Responsibilities
- Lead a Quality Operations team supporting GMP manufacturing/testing, including disposition of intermediates, working cell banks, and clinical/commercial drug products.
- Manage QA On The Floor and QA Walkthrough programs for Vertex GMP facilities.
- Serve as Quality Lead for assigned clinical programs; provide GCP compliance interpretation, consultation, and support to protect subjects and ensure data integrity.
- Liaise with clinical functions and external parties (CROs, vendors, investigator sites) to promote quality and consistency.
- Provide QA protocol review; participate on Operational Review Boards to identify risks and develop mitigation strategies.
- Develop and execute risk-based audit plans; review audit reports, CAPA plans, and responses; manage domestic/international audits of clinical investigators.
- Lead quality issue investigations, root cause analysis, CAPA development, and implementation support.
- Support continuous quality improvement and inspection readiness; provide inspection support for regulatory agencies.
- May serve as GCP Quality Management System representative; participate in SOP/WI review.
- Review performance indicators/trends; analyze risk and propose remedial/corrective/preventive actions.
- People management: recruiting/onboarding, performance management, engagement/retention support, succession planning, coaching/training/IDPs; oversee day-to-day operations; assist budgeting/scheduling and workforce planning.
Qualifications/Skills
- In-depth cGMP knowledge and global GMP requirements; manage quality for GMP manufacturing.
- Demonstrated leadership building high-performing teams; mentoring and technical knowledge transfer.
- Strong project/meeting/planning skills; ability to lead cross-functional teams and influence stakeholders.
- Risk-based decision-making; proven experience with investigations, RCA, and CAPA.
- Experience with regulatory inspections across applicable GxPs; electronic document systems (e.g., QDoccs, Trackwise, Veeva).
- Bachelor’s degree in a scientific/allied health field (or equivalent).
- Typically 8 years’ experience and 2 years’ management experience (or equivalent).
Location/Shift: On-Site at Vertex’s Leiden Center Building (LC1), 316-318 Northern Ave, Boston, MA 02210. 1st shift B1: Wed–Sat 7:00am–5:30pm.
Responsibilities
- Lead a Quality Operations team supporting GMP manufacturing/testing, including disposition of intermediates, working cell banks, and clinical/commercial drug products.
- Manage QA On The Floor and QA Walkthrough programs for Vertex GMP facilities.
- Serve as Quality Lead for assigned clinical programs; provide GCP compliance interpretation, consultation, and support to protect subjects and ensure data integrity.
- Liaise with clinical functions and external parties (CROs, vendors, investigator sites) to promote quality and consistency.
- Provide QA protocol review; participate on Operational Review Boards to identify risks and develop mitigation strategies.
- Develop and execute risk-based audit plans; review audit reports, CAPA plans, and responses; manage domestic/international audits of clinical investigators.
- Lead quality issue investigations, root cause analysis, CAPA development, and implementation support.
- Support continuous quality improvement and inspection readiness; provide inspection support for regulatory agencies.
- May serve as GCP Quality Management System representative; participate in SOP/WI review.
- Review performance indicators/trends; analyze risk and propose remedial/corrective/preventive actions.
- People management: recruiting/onboarding, performance management, engagement/retention support, succession planning, coaching/training/IDPs; oversee day-to-day operations; assist budgeting/scheduling and workforce planning.
Qualifications/Skills
- In-depth cGMP knowledge and global GMP requirements; manage quality for GMP manufacturing.
- Demonstrated leadership building high-performing teams; mentoring and technical knowledge transfer.
- Strong project/meeting/planning skills; ability to lead cross-functional teams and influence stakeholders.
- Risk-based decision-making; proven experience with investigations, RCA, and CAPA.
- Experience with regulatory inspections across applicable GxPs; electronic document systems (e.g., QDoccs, Trackwise, Veeva).
- Bachelor’s degree in a scientific/allied health field (or equivalent).
- Typically 8 years’ experience and 2 years’ management experience (or equivalent).